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Phase 3 Completed N=466 Randomized Treatment

A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01582451 ↗
Enrolled (actual)
466
Serious AEs
12.5%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c) — -0.82; -0.29 percentage of HbA1c
◆ Published Evidence
Highly cited
185citations · ~21 / year
Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes.
Diabetes, obesity & metabolism · 2017 · Likely link

Summary

The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low blood sugar episodes at night * The rate of low blood sugar episodes reported over a 24-hour period

Linked Publications (5)

  • Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes.
    Diabetes, obesity & metabolism · 2017 · 185 citations · Likely link
  • Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5.
    Diabetes care · 2016 · 83 citations · Open access · Likely link
  • Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
    Therapeutic innovation & regulatory science · 2023 · 5 citations · Likely link
  • Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins.
    Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2018 · 4 citations · Likely link
  • The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes.
    Cardiovascular diabetology · 2017 · 4 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
-0.82; -0.29
SECONDARY
Change From Baseline to 52 Weeks in HbA1c
-0.67; -0.22
SECONDARY
Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)
1.55; 1.98; 1.24; 1.62; 0.43; 1.04
SECONDARY
Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events
76.3; 80.5; 80.3; 83.0; 46.1; 62.3
SECONDARY
Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%
50.3; 28.7; 43.4; 28.0; 72.5; 52.2
SECONDARY
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
40.1; 18.5; 34.8; 10.2
SECONDARY
Fasting Serum Glucose (FSG) (by Laboratory)
103.80; 119.50; 107.61; 115.74
SECONDARY
Fasting Blood Glucose (FBG) (by Self Monitoring)
106.32; 104.50; 110.61; 107.46
SECONDARY
Intra-participant Variability in Fasting Blood Glucose (FBG)
13.70; 17.90; 14.18; 17.38
SECONDARY
6-point Self-monitored Blood Glucose (SMBG)
107.93; 104.11; 120.87; 132.56; 125.87; 141.45
SECONDARY
HbA1c
6.60; 7.13; 6.75; 7.20
SECONDARY
Insulin Dose Per Kilogram of Body Weight
0.57; 0.49; 0.58; 0.49
SECONDARY
Number of Insulin Dose Adjustments to Steady-state
4.06; 2.75
SECONDARY
European Quality of Life - 5 Dimension (EuroQol-5D) Score
0.87; 0.88
SECONDARY
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
85.69; 84.43
SECONDARY
Adult Low Blood Sugar Survey (LBSS) Score
16.57; 15.63
SECONDARY
Change From Baseline in Body Weight
0.50; 0.94; 0.69; 1.32
SECONDARY
Change From Baseline in Lipid Profile
2.24; 3.70; -1.35; 2.78; -1.74; -0.06
SECONDARY
Number of Participants With Change in Anti-LY2605541 Antibodies
70; 30

Eligibility Criteria

Inclusion Criteria

  • Have had type 2 diabetes mellitus for at least 1 year
  • Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
  • Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
  • Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
  • Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Exclusion Criteria

  • Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
  • Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
  • For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
  • Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
  • Have had any episodes of severe hypoglycemia within 6 months prior to screening
  • Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L])
  • Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
  • Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
  • Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  • Lipid-lowering medication: Are using or have used any of the following:
  • niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
  • lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01582451) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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